Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-25 @ 9:09 PM
Study NCT ID:
NCT04710966
Status:
COMPLETED
Last Update Posted:
2021-01-15
First Post:
2021-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Arthroscopic Debridement and Repair for Partial-thickness Rotator Cuff Tears
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}], 'ancestors': [{'id': 'D012421', 'term': 'Rupture'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Whereas patients and surgeons were aware of the group assignments, the outcome assessors and data analysts were remained blinded during the study period.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Before initiating the trial, an investigator who was not involved in the study generated a computer-generated randomization list (block length 10, ratio 1:1). Allocation concealment was achieved by using opaque, sealed, sequentially numbered envelopes containing details of group assignment. Assignment occurred after baseline information was recorded. According to preoperative allocation, the patients were given arthroscopic debridement or repair respectively.For the debridement group, only stump refreshing and surrounding soft tissue cleaning were performed. For the repair group, we converted partial tears into full-thickness tears and sutured them'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 179}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-12', 'studyFirstSubmitDate': '2021-01-06', 'studyFirstSubmitQcDate': '2021-01-12', 'lastUpdatePostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Visual Analog Scale score', 'timeFrame': 'Baseline', 'description': 'Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).'}, {'measure': 'The Visual Analog Scale score', 'timeFrame': 'Postoperative 6 months', 'description': 'Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).'}, {'measure': 'The Visual Analog Scale score', 'timeFrame': 'Postoperative 12 months', 'description': 'Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).'}, {'measure': 'The Visual Analog Scale score', 'timeFrame': 'Postoperative 18 months', 'description': 'Assess pain on a scale of 0 (no pain) to 10 (worst possible pain).'}, {'measure': 'Constant-Murray Shoulder score', 'timeFrame': 'Baseline', 'description': 'An assessment method often used by orthopedic surgeons when assessing the condition of patients with shoulder joints. Possible scores range from 0 to 100，a higher score means a better result.'}, {'measure': 'Constant-Murray Shoulder score', 'timeFrame': 'postoperative 6 months', 'description': 'An assessment method often used by orthopedic surgeons when assessing the condition of patients with shoulder joints.Possible scores range from 0 to 100，a higher score means a better result.'}, {'measure': 'Constant-Murray Shoulder score', 'timeFrame': 'postoperative 12 months', 'description': 'An assessment method often used by orthopedic surgeons when assessing the condition of patients with shoulder joints.Possible scores range from 0 to 100，a higher score means a better result.'}, {'measure': 'Constant-Murray Shoulder score', 'timeFrame': 'postoperative 18 months', 'description': 'An assessment method often used by orthopedic surgeons when assessing the condition of patients with shoulder joints.Possible scores range from 0 to 100，a higher score means a better result.'}, {'measure': 'American Shoulder and Elbow Surgeon score', 'timeFrame': 'Baseline', 'description': "The evaluation criteria used to assess shoulder joint function based on the patients' pain and accumulated daily activities. Possible scores range from 0 to 100. The higher the score, the better the shoulder joint function."}, {'measure': 'American Shoulder and Elbow Surgeon score', 'timeFrame': 'postoperative 6 months', 'description': "The evaluation criteria used to assess shoulder joint function based on the patients' pain and accumulated daily activities. Possible scores range from 0 to 100. The higher the score, the better the shoulder joint function."}, {'measure': 'American Shoulder and Elbow Surgeon score', 'timeFrame': 'postoperative 12 months', 'description': "The evaluation criteria used to assess shoulder joint function based on the patients' pain and accumulated daily activities. Possible scores range from 0 to 100. The higher the score, the better the shoulder joint function."}, {'measure': 'American Shoulder and Elbow Surgeon score', 'timeFrame': 'postoperative 18 months', 'description': "The evaluation criteria used to assess shoulder joint function based on the patients' pain and accumulated daily activities. Possible scores range from 0 to 100. The higher the score, the better the shoulder joint function."}, {'measure': 'University of California-Los Angeles score', 'timeFrame': 'Baseline', 'description': 'The score mainly consists of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint mobility and muscle strength. Possible scores range from 0 to 35, a higher score means a better result.'}, {'measure': 'University of California-Los Angeles score', 'timeFrame': 'postoperative 6 months', 'description': 'The score mainly consists of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint mobility and muscle strength. Possible scores range from 0 to 35, a higher score means a better result.'}, {'measure': 'University of California-Los Angeles score', 'timeFrame': 'postoperative 12 months', 'description': 'The score mainly consists of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint mobility and muscle strength. Possible scores range from 0 to 35, a higher score means a better result.'}, {'measure': 'University of California-Los Angeles score', 'timeFrame': 'postoperative 18 months', 'description': 'The score mainly consists of two parts. Patients subjectively evaluate pain and functional activity; and doctors objectively evaluate shoulder joint mobility and muscle strength. Possible scores range from 0 to 35, a higher score means a better result.'}], 'secondaryOutcomes': [{'measure': 'Grading of rotator cuff integrity', 'timeFrame': '18 months after surgery', 'description': 'The integrity of the rotator cuff was assessed by magnetic resonance imaging (MRI) according to a grading criteria, as follows: Grade I and II, sufficient thickness with low or partial high intensity; Grade III, insufficient thickness without discontinuity; Grade IV and V, presence of a minor or major discontinuity.'}, {'measure': 'Grading of muscle atrophy', 'timeFrame': '18 months after surgery', 'description': "Muscular atrophy was assessed on oblique sagittal MRI images using an occupation ratio measured by dividing the supraspinatus muscle's cross-sectional area by that of the supraspinatus fossa on the oblique-sagittal view. When the ratio was between 1.00 and 0.60, the muscle was considered normal or with slight atrophy (Grade I); values between 0.60 and 0.40 indicated moderate atrophy (Grade II); values below 0.40 indicated severe atrophy (Grade III)."}, {'measure': 'Grading of fatty degeneration', 'timeFrame': '18 months after surgery', 'description': 'Fatty degeneration in supraspinatus muscle was assessed by magnetic resonance imaging (MRI) according to a grading system with stages 0-4 as follows: grade 0, no fat; Grade 1, thin fatty streaks; Grade 2, heavy fat infiltration, with muscle still pre-dominating; Grade 3, even distribution of fat and muscle; Grade 4, more fat than muscle.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['partial-thickness', 'bursal-side tear', 'rotator cuff tears', 'arthroscopic debridement', 'arthroscopic repair'], 'conditions': ['Rotator Cuff Tears']}, 'referencesModule': {'references': [{'pmid': '2182260', 'type': 'RESULT', 'citation': 'Ellman H. Diagnosis and treatment of incomplete rotator cuff tears. Clin Orthop Relat Res. 1990 May;(254):64-74.'}, {'pmid': '25535097', 'type': 'RESULT', 'citation': 'Chung SW, Kim JY, Yoon JP, Lyu SH, Rhee SM, Oh SB. Arthroscopic repair of partial-thickness and small full-thickness rotator cuff tears: tendon quality as a prognostic factor for repair integrity. Am J Sports Med. 2015 Mar;43(3):588-96. doi: 10.1177/0363546514561004. Epub 2014 Dec 22.'}, {'pmid': '25143642', 'type': 'RESULT', 'citation': 'Kwon OS, Kelly JI. Outcome analysis of arthroscopic treatment of partial thickness rotator cuff tears. Indian J Orthop. 2014 Jul;48(4):385-9. doi: 10.4103/0019-5413.136249.'}, {'pmid': '21296545', 'type': 'RESULT', 'citation': 'Strauss EJ, Salata MJ, Kercher J, Barker JU, McGill K, Bach BR Jr, Romeo AA, Verma NN. Multimedia article. The arthroscopic management of partial-thickness rotator cuff tears: a systematic review of the literature. Arthroscopy. 2011 Apr;27(4):568-80. doi: 10.1016/j.arthro.2010.09.019.'}, {'pmid': '11912097', 'type': 'RESULT', 'citation': 'Cordasco FA, Backer M, Craig EV, Klein D, Warren RF. The partial-thickness rotator cuff tear: is acromioplasty without repair sufficient? Am J Sports Med. 2002 Mar-Apr;30(2):257-60. doi: 10.1177/03635465020300021801.'}, {'pmid': '17084305', 'type': 'RESULT', 'citation': 'Wolff AB, Magit DP, Miller SR, Wyman J, Sethi PM. Arthroscopic fixation of bursal-sided rotator cuff tears. Arthroscopy. 2006 Nov;22(11):1247.e1-4. doi: 10.1016/j.arthro.2006.05.026.'}, {'pmid': '32499197', 'type': 'RESULT', 'citation': 'Zhang Y, Zhai S, Qi C, Chen J, Li H, Zhao X, Yu T. A comparative study of arthroscopic debridement versus repair for Ellman grade II bursal-side partial-thickness rotator cuff tears. J Shoulder Elbow Surg. 2020 Oct;29(10):2072-2079. doi: 10.1016/j.jse.2020.03.006. Epub 2020 Jun 1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to conduct a prospective randomized controlled trial to compare the effects of arthroscopic debridement and repair for Ellman grade II bursal-side partial-thickness rotator cuff tears.The hypothesis was that there would be no difference in prognosis between arthroscopic debridement and repair.', 'detailedDescription': 'This was a single-center, prospective, double-blinded, randomized controlled trial, comparing arthroscopic debridement and arthroscopic repair for Ellman grade II BPTRCTs. Participants were recruited from September 2017 to April 2019. Before initiating the trial, an investigator who was not involved in the study generated a computer-generated randomization list (block length 10, ratio 1:1). Allocation concealment was achieved by using opaque, sealed, sequentially numbered envelopes containing details of group assignment. Assignment occurred after baseline information was recorded. Whereas participants and surgeons were aware of the group assignments, the outcome assessors and data analysts were remained blinded during the study period. Operations were performed by the same team of sports medicine surgeons under general anesthesia. For the debridement group, only stump refreshing and surrounding soft tissue cleaning were performed. For the repair group, partial tears were converted into full-thickness tears and sutured. The sample size calculation was based on data from previous studies, where the difference in Constant-Murray Shoulder (CMS) score between patients with arthroscopic repair and arthroscopic debridement was 8.81 points (93.90 vs. 85.09) with standard deviations of 5.4 and 21. Accepting an α risk of 0.05 and a β risk of 0.2 in a bilateral contrast, the minimum sample size required for each group was 35. To compensate for an estimated 15% loss to follow up, at least 82 patients would be included.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Bursal-side partial-thickness rotator cuff tears (BPTRCTs) revealed by magnetic resonance imaging (MRI)\n* Failed of conservative treatment for more than 3 months\n* Intraoperative arthroscopic confirmed that the tear was Ellman grade II\n\nExclusion Criteria:\n\n* Previous surgical surgery on the shoulder\n* Articular-side or intratendinous rotator cuff tears\n* Combined articular-side partial-thickness rotator cuff tears(APRCTs) and Bursal-side partial-thickness rotator cuff tears (BPRCTs), or full-thickness rotator cuff tears (RCTs)\n* Combined with other shoulder lesions that need to be addressed, such as biceps tendon disorders, labral tears\n* The presence of other diseases that affect shoulder function\n* Contraindication to arthroscopic surgery or anesthesia'}, 'identificationModule': {'nctId': 'NCT04710966', 'briefTitle': 'Comparison Between Arthroscopic Debridement and Repair for Partial-thickness Rotator Cuff Tears', 'organization': {'class': 'OTHER', 'fullName': 'The Affiliated Hospital of Qingdao University'}, 'officialTitle': 'Comparison Between Arthroscopic Debridement and Repair for Ellman Grade II Bursal-side Partial-thickness Rotator Cuff Tears: a Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'wangteng'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'debridement group', 'description': 'For the debridement group, if the tear type is confirmed to be bursal-side Ellman grade II during the operation, arthroscopic debridement will be performed.', 'interventionNames': ['Procedure: arthroscopic debridement']}, {'type': 'EXPERIMENTAL', 'label': 'repair group', 'description': 'For the repair group, if the tear type is confirmed to be bursal-side Ellman grade II during the operation, arthroscopic repair will be performed.', 'interventionNames': ['Procedure: arthroscopic repair']}], 'interventions': [{'name': 'arthroscopic debridement', 'type': 'PROCEDURE', 'description': 'For the arthroscopic debridement, only stump refreshing and surrounding soft tissue cleaning were performed.', 'armGroupLabels': ['debridement group']}, {'name': 'arthroscopic repair', 'type': 'PROCEDURE', 'description': 'For the arthroscopic repair, we converted partial tears into full-thickness tears and sutured them.', 'armGroupLabels': ['repair group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '266000', 'city': 'Qingdao', 'country': 'China', 'facility': 'Affiliated Hospital of Qingdao University', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}], 'overallOfficials': [{'name': 'Teng Wang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Investigator'}, {'name': 'Tengbo Yu', 'role': 'STUDY_CHAIR', 'affiliation': 'professor'}]}, 'ipdSharingStatementModule': {'url': 'http://www.medresman.org.cn/uc/sindex.aspx', 'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Beginning 9 months and ending 36 months following article publication.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)', 'accessCriteria': 'Proposals should be directed to wt10113277@163.com. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website .'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Affiliated Hospital of Qingdao University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}